TUMT verses Medical Therapy in Treatment of BPH

TUMT 与药物治疗治疗 BPH 的比较

• 批准号: 6667026
• 负责人: E DAVID CRAWFORD
• 金额: $ 25万
• 依托单位: UNIVERSITY OF COLORADO DENVER
• 依托单位国家: 美国
• 财政年份: 2001
• 资助国家: 美国
• 起止时间: 2001-09-30 至 2006-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6667026
• 关键词: adult human (21+); antiadrenergic agents; benign prostate hyperplasia; blood tests; clinical trials; cooperative study; diagnosis design /evaluation; disease /disorder prevention /control; health care cost /financing; human subject; human therapy evaluation; hyperthermia therapy; longitudinal human study; male; microwave radiation; outcomes research; patient oriented research; prognosis; reproductive system disorder chemotherapy; statistics /biometry; ultrasonography; urinalysis; urinary catheterization

DESCRIPTION (provided by applicant): Lower urinary tract symptoms (LUTS) suggestive of benign prostatic obstruction (BPO) are common in the aging male. There are few well-designed, long-term, mufti-center randomized clinical trials comparing the subjective and objective outcomes of minimally invasive surgical therapies (MIST). AIM 1.To participate in the collaborative Prostate Evaluation and Treatment Centers (PETCs) that will develop: a) Standardized assessment instruments for the diagnosis and classification of symptomatic BPH in men above the age of 50; b) Clinical trial protocols that will compare the outcomes of treatments to improve symptomatic BPH. The primary focus of Aim 1 is to incorporate our BPH research team as PETC. The PI and the BPH research team assembled for this project have had broad experience in the design, implementation and analysis of BPH research. We have successfully participated in 10 BPH trials including 2 VA Cooperative trials, pharmaceutical sponsored trials, a local investigator initiated trial, and both phases of the Medical Therapy of Prostatic Symptoms trials (MTOPS). Our patient retention and adherence has consistently been in the top 25 percent. The medical center hospitals provide more than an adequate number of patients to meet recruitment goals. AIM 2. To establish and implement a prospective randomized controlled trial for treatment of BPH that will: a) establish the treatment outcome for medical therapy versus minimally invasive therapy as the primary mode of therapy; b) determine which of the following predict successful treatment outcomes: 1) Patient characteristics including AUA symptoms score, uroflow rate, and prostate size; 2) Urodynamic parameters; 3) determine the cost of achieving the treatment outcome. The goal of Aim 2 is a randomized clinical trial (RCT) to evaluate the efficacy and effectiveness of the minimally invasive therapy of transurethral microwave thermotherapy (TUMT). Our hypothesis is that TUMT in patients with minimal or moderate symptoms secondary to BPH will be both more efficicacious and effective than medical therapy and reduce overall health care dollars expenditures. The RCT will compare the best arm of the current MTOPS trial to TUMT. TUMT was chosen as the MIST, because it meets the criteria of being truly "minimally invasive." Unfortunately, there has been lack of uniform entry criteria, lack of consistent follow-up and scarce data on long-term outcomes (effectiveness) and costs. The RCT will compare a sham TUMT and medical therapy to TUMT treatment in a double blind manner. Medical therapy was chosen over TURP for the comparison because there is more "overlap" of TUMT with this therapy than with transurethral resection of the prostate (TURP) (Figure 1). Health care economics dictate that the short and long-term costs of BPH therapy need to be addressed. The PI has enlisted the support of consultants who will assist in this important evaluation. The results of this analysis will be critical in allocating health care resources.

描述（由申请人提供）： 下尿路症状（LUTS）提示良性前列腺梗阻 (BPO)常见于老年男性很少有精心设计的，长期的， 多中心随机临床试验，比较主观和客观 微创手术治疗（MIST）的结果。 目的1.参与前列腺评估和治疗的合作 （a）标准化评估工具， 50岁以上男性症状性BPH的诊断和分类; B）将治疗结果与以下结果进行比较的临床试验方案： 改善BPH症状。目标1的主要重点是纳入我们的BPH 研究团队为PETC。PI和BPH研究团队为此聚集在一起 项目在设计、实施和分析方面有着广泛的经验， BPH研究。我们已经成功参与了10项BPH试验，包括2项VA 合作试验、药物申办试验、当地研究者 启动的试验，以及前列腺症状药物治疗的两个阶段 试验（MTOPS）。我们的患者保留率和依从性一直保持在 前25%。医疗中心医院提供了足够的 达到招募目标的患者数量。 AIM 2.建立并实施一项前瞻性随机对照试验， BPH的治疗，将：a）建立医疗的治疗结果 治疗相对于作为主要治疗模式的微创治疗; B） 确定以下哪项预测成功的治疗结果：1） 患者特征，包括AUA症状评分、尿流率和 前列腺大小; 2）尿动力学参数; 3）确定实现 治疗结果目标2的目标是一项随机临床试验（RCT）， 评估微创治疗的疗效和有效性， 经尿道微波热疗（TUMT）。我们的假设是， 继发于BPH的轻微或中度症状的患者将更多 比药物治疗更有效，并减少整体医疗保健 美元支出。RCT将比较当前MTOPS的最佳组 审判Tumt TUMT被选为MIST，因为它符合以下标准 真正的“微创”。“不幸的是， 进入标准，缺乏连贯的后续行动，缺乏长期的 成本（effectiveness）和成本。RCT将比较假TUMT和 以双盲方式将药物治疗与TUMT治疗进行比较。药物治疗是 选择TURP进行比较，因为TUMT有更多的“重叠” 经尿道前列腺电切术（TURP） （图1）。卫生保健经济学规定， BPH的治疗需要注意。PI已经获得了 将协助进行这项重要评估的顾问。的结果 在分配医疗资源时，分析将是至关重要的。